(449 days)
Not Found
Yes
The device description explicitly states that it "utilizes artificial intelligence learning algorithms".
No
Explanation: A therapeutic device is used to treat a disease or condition. This device is an image processing software that assists in prioritizing cases of suspected intracranial hemorrhage, which is a diagnostic assistance function, not a therapeutic one.
No
The "Intended Use / Indications for Use" section explicitly states, "The output is intended for informational purposes only and is not intended for diagnostic use. The device does not alter the original medical image and is not intended to be used as a stand-alone diagnostic device."
Yes
The device description explicitly states it is "image processing software" and provides a "pipeline for the analysis and identification of potential ICH as well as a finding notification mechanism." There is no mention of any associated hardware components being part of the device itself.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device's function: syngo.CT Brain Hemorrhage processes medical images (CT scans of the head) that are already acquired from the patient. It does not analyze biological specimens.
- Intended Use statement: The intended use clearly states it's designed to "assist the radiologist in prioritizing cases" and is "for informational purposes only and is not intended for diagnostic use." This further reinforces that it's not performing a diagnostic test on a biological sample.
Therefore, based on the provided information, syngo.CT Brain Hemorrhage is a medical image processing software, not an In Vitro Diagnostic device.
No
The provided document explicitly states "Control Plan Authorized (PCCP) and relevant text: Not Found". This means there is no mention of a PCCP being reviewed, approved, or cleared for this specific device.
Intended Use / Indications for Use
syngo.CT Brain Hemorrhage is designed to assist the radiologist in prioritizing cases of suspected intracranial hemorrhage on non-contrast CT examinations of the head. It makes case-level output available to a CT scanner or other PACS system for worklist prioritization. The output is intended for informational purposes only and is not intended for diagnostic use. The device does not alter the original medical image and is not intended to be used as a stand-alone diagnostic device.
Product codes
QAS
Device Description
The subject device syngo.CT Brain Hemorrhage is an image processing software that utilizes artificial intelligence learning algorithms to support qualified clinicians in analysis and prioritization of noncontrast head CT DICOM images by algorithmically identifying findings suspicious of acute intracranial hemorrhage. The subject device provides a pipeline for the analysis and identification of potential ICH as well as a finding notification mechanism.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Non-contrast CT
Anatomical Site
Head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital networks and qualified clinicians / Acute Care
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The data cohort consisted of 600 anonymized head CT cases from 5 sites in US and Europe with approximately equal distribution of positive (case with ICH) and negative (case without ICH) cases. Ground truth was established by majority read of 3 US board certified neuroradiologists with more than 10 years of experience.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Evaluation of the Algorithm: The performance of the syngo.CT Brain Hemorrhage device has been validated in a retrospective standalone performance study. Sensitivity and specificity of syngo.CT Brain Hemorrhage in processing of non-contrast head CT have been analyzed by comparison to a ground truth established by majority read of 3 US board certified neuroradiologists with more than 10 years of experience. The data cohort consisted of 600 anonymized head CT cases from 5 sites in US and Europe with approximately equal distribution of positive (case with ICH) and negative (case without ICH) cases. Sensitivity was observed to be 92.8% (95% CI: 89.3%-95.2%). Specificity was observed to be 94.5% (95% CI: 91.3%-96.5%). Thus, sensitivity and specificity exceeded the 80% performance goal. The average per-case processing time was 13.67 seconds (95% CI: 7.48-19.86 seconds).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 92.8% (95% CI: 89.3%-95.2%)
Specificity: 94.5% (95% CI: 91.3%-96.5%)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2080 Radiological computer aided triage and notification software.
(a)
Identification. Radiological computer aided triage and notification software is an image processing prescription device intended to aid in prioritization and triage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis of those images performed by the device. The device does not mark, highlight, or direct users' attention to a specific location in the original image. The device does not remove cases from a reading queue. The device operates in parallel with the standard of care, which remains the default option for all cases.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) A detailed description of the notification and triage algorithms and all underlying image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, how the algorithm affects or relates to clinical practice or patient care, and any algorithm limitations.
(ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will provide effective triage (
e.g., improved time to review of prioritized images for pre-specified clinicians).(iii) Results from performance testing that demonstrate that the device will provide effective triage. The performance assessment must be based on an appropriate measure to estimate the clinical effectiveness. The test dataset must contain sufficient numbers of cases from important cohorts (
e.g., subsets defined by clinically relevant confounders, effect modifiers, associated diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals for these individual subsets can be characterized with the device for the intended use population and imaging equipment.(iv) Stand-alone performance testing protocols and results of the device.
(v) Appropriate software documentation (
e.g., device hazard analysis; software requirements specification document; software design specification document; traceability analysis; description of verification and validation activities including system level test protocol, pass/fail criteria, and results).(2) Labeling must include the following:
(i) A detailed description of the patient population for which the device is indicated for use;
(ii) A detailed description of the intended user and user training that addresses appropriate use protocols for the device;
(iii) Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level (
e.g., poor image quality for certain subpopulations), as applicable;(iv) A detailed description of compatible imaging hardware, imaging protocols, and requirements for input images;
(v) Device operating instructions; and
(vi) A detailed summary of the performance testing, including: test methods, dataset characteristics, triage effectiveness (
e.g., improved time to review of prioritized images for pre-specified clinicians), diagnostic accuracy of algorithms informing triage decision, and results with associated statistical uncertainty (e.g., confidence intervals), including a summary of subanalyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
Siemens Medical Solutions USA, Inc. % Tabitha Estes Regulatory Affairs Specialist 810 Innovation Drive KNOXVILLE TN 37932
Re: K203260
January 28, 2022
Trade/Device Name: syngo.CT Brain Hemorrhage Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: Class II Product Code: QAS Dated: December 15, 2021 Received: December 17, 2021
Dear Tabitha Estes:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203260
Device Name syngo.CT Brain Hemorrhage
Indications for Use (Describe)
syngo.CT Brain Hemorrhage is designed to assist the radiologist in prioritizing cases of suspected intracranial hemorrhage on non-contrast CT examinations of the head. It makes case-level output available to a CT scanner or other PACS system for worklist prioritization. The output is intended for informational purposes only and is not intended for diagnostic use. The device does not alter the original medical image and is not intended to be used as a stand-alone diagnostic device.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY FOR SYNGO.CT BRAIN HEMORRHAGE
K203260
Date Prepared: January 26th, 2022
Identification of the Submitter
Importer/Distributor Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number 2240869
Manufacturing Site Siemens Healthcare GmbH Siemensstr 1 D-91301 Forchheim, Germany
Establishment Registration Number 3004977335
Submitter Contact Person:
Tabitha Estes Regulatory Affairs Specialist Siemens Medical Solutions, Inc. USA 810 Innovation Drive Knoxville, TN 37932 Phone: (865) 804-4553 Email: tabitha.estes(@siemens-healthineers.com
Alternate Contact: Alaine Medio
I. Device Name and Classification
Product Name: syngo.CT Brain Hemorrhage Propriety Trade Name: syngo.CT Brain Hemorrhage Classification Name: Radiological Computer-Assisted Triage and Notification Software Classification Panel: Radiology 21 CFR §892.2080 CFR Section: Device Class: Class II Product Code: QAS
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II. Predicate Device
| Trade Name: | Accipiolx |
|---|---|
| 510(k) Number: | K182177 |
| Clearance Date: | 07/26/2019 |
| Classification Name: | Radiological Computer-Assisted Triage and Notification Software |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.2080 |
| Device Class: | Class II |
| Product Code: | QAS |
III. Device Description
The subject device syngo.CT Brain Hemorrhage is an image processing software that utilizes artificial intelligence learning algorithms to support qualified clinicians in analysis and prioritization of noncontrast head CT DICOM images by algorithmically identifying findings suspicious of acute intracranial hemorrhage. The subject device provides a pipeline for the analysis and identification of potential ICH as well as a finding notification mechanism.
IV. Indications for Use
syngo.CT Brain Hemorrhage is designed to assist the radiologist in prioritizing cases of suspected intracranial hemorrhage on non-contrast CT examinations of the head. It makes case-level output available to a CT scanner or other PACS system for worklist prioritization. The output is intended for informational purposes only and is not intended for diagnostic use. The device does not alter the original medical image and is not intended to be used as a stand-alone diagnostic device.
V. Comparison of Technological Characteristics with the Predicate Device
The differences and similarities between the above referenced predicate device are listed at a high-level in the following table:
| Feature | Subject Device | Predicate Device | Comparison
Table |
|----------------------------------------------------------------|-----------------------------------------------|-----------------------------------------------|---------------------|
| | syngo.CT Brain Hemorrhage | MaxQ-AI Accipiolx | |
| Notification-only, parallel
workflow tool | Yes | Yes | Same |
| Intended User | Hospital networks and qualified
clinicians | Hospital networks and qualified
clinicians | Same |
| Setting | Acute Care | Acute Care | Same |
| Identify patients with a
prespecified clinical
condition | Yes | Yes | Same |
| Clinical condition | Intracranial hemorrhage | Intracranial hemorrhage | Same |
| Alert to finding | Yes; flagged for review | Yes; flagged for review | Same |
| Independent of standard
of care workflow | Yes; No cases are removed from
worklist | Yes; No cases are removed from
worklist | Same |
| Modality | Non-contrast CT | Non-contrast CT | Same |
| Body Part | Head | Head | Same |
| Artificial Intelligence
algorithm | Yes | Yes | Same |
| Limited to analysis of
imaging data | Yes | Yes | Same |
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| Feature | Subject Device | Predicate Device | Comparison Table |
|---|---|---|---|
| Output | syngo.CT Brain Hemorrhage | MaxQ-AI Accipiolx | Same |
| Suspected hemorrhage / No suspected hemorrhage | Suspected hemorrhage / No suspected hemorrhage |
The subject device syngo.CT Brain Hemorrhage does not have changes in fundamental scientific technology compared to the predicate device. The post-processing software functionality remains unchanged from the subject device and the predicate device. The operating principle and the scientific technology are the same; therefore, Siemens believes that syngo.CT Brain Hemorrhage application is substantially equivalent to the predicate device.
VI. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Non-Clinical Testing
Non-clinical tests (integration and functional) were conducted for syngo.CT Brain Hemorrhage during product development. These tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The results of all conducted testing were found acceptable to support the claim of substantial equivalence.
Performance Evaluation of the Algorithm
The performance of the syngo.CT Brain Hemorrhage device has been validated in a retrospective standalone performance study. Sensitivity and specificity of syngo.CT Brain Hemorrhage in processing of non-contrast head CT have been analyzed by comparison to a ground truth established by majority read of 3 US board certified neuroradiologists with more than 10 years of experience. The data cohort consisted of 600 anonymized head CT cases from 5 sites in US and Europe with approximately equal distribution of positive (case with ICH) and negative (case without ICH) cases.
Sensitivity was observed to be 92.8% (95% CI: 89.3%-95.2%). Specificity was observed to be 94.5% (95% CI: 91.3%-96.5%). Thus, sensitivity and specificity exceeded the 80% performance goal.
The average per-case processing time was 13.67 seconds (95% CI: 7.48-19.86 seconds). This is comparable to the predicate device.
To conclude, syngo.CT Brain Hemorrhage is a safe and effective triage and notification device for intracranial hemorrhages which is substantially equivalent to the predicate device.
Siemens hereby certifies that syngo.CT Brain Hemorrhage will meet the following voluntary standards covering electrical and mechanical safety listed below, prior to introduction into interstate commerce:
| Recognition
Number | Product
Area | Title of Standard | Date of
Recognition | Standards
Development
Organization |
|-----------------------|--------------------------|------------------------------------------------------------------------------------------------------------|------------------------|------------------------------------------|
| 12-300 | Radiology | Digital Imaging and Communications in
Medicine (DICOM) Set; PS 3.1 - 3.20 | 06/27/2016 | NEMA |
| 13-79 | Software | Medical Device Software -Software Life Cycle
Processes; 62304:2006 (1st Edition) | 01/14/2019 | AAMI, ANSI,
IEC |
| 5-40 | Software/
Informatics | Medical devices – Application of risk
management to medical devices; 14971 Second
Edition 2007-03-01 | 06/27/2016 | ISO |
| 5-114 | General I
(QS/RM) | Medical devices - Part 1: Application of
usability engineering to medical devices
IEC 62366-1:2015 | 12/23/2016 | IEC |
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VII. Conclusion
syngo.CT Brain Hemorrhage has the same intended use and similar indication for use as the predicate device. The result of all testing conducted was found acceptable to support the claim of substantial equivalence. The comparison of technological characteristics, clinical and non-clinical performance data, and software validation demonstrates that the subject device is as safe and effective when compared to the predicate device that is currently marketed for the same intended use. Siemens considers syngo.CT Brain Hemorrhage to be as safe, as effective and with performance substantially equivalent to the commercially available predicate device.